An interventional study of Cataract Refractive Suite (CRS) and Standard manual technique in Cataracts, sponsored by Alcon, a Novartis Company. Terminated at 3 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Not applicable, Interventional, and Treatment
The purpose of this study is to compare the refractive predictability (prediction error) between the Cataract Refractive Suite (CRS) and standard manual technique at one month post-operative
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 39 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Alcon left Novartis.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
First surgical eye randomized to Cataract Refractive Suite with second surgical eye (fellow eye) assigned to standard manual technique. Second eye surgery conducted within 7-14 days of the first eye surgery.
Device: Cataract Refractive Suite (CRS) · Procedure: Standard manual technique
First surgical eye randomized to standard manual technique with second surgical eye (fellow eye) assigned to Cataract Refractive Suite. Second eye surgery conducted within 7-14 days of the first eye surgery.
Device: Cataract Refractive Suite (CRS) · Procedure: Standard manual technique
Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery
Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1
Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Time frame: Day 20-40 from second implantation
Cumulative Dissipated Energy (CDE)
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Time frame: Day 0 (operative day), each eye
Estimated Aspiration Fluid Used During Surgery
Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Time frame: Day 0 (operative day), each eye
Phaco Aspiration Time Spent During Surgery
Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
Time frame: Day 0 (operative day), each eye
Subjects were recruited from 3 investigative sites located in the United States.
| Milestone | All Study Subjects |
|---|---|
| Started | 39 |
| Crs (left or right eye) | 38 |
| Manual (fellow eye) | 38 |
| Completed | 0 |
| Not completed | 39 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Study terminated by sponsor | 36 |
Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
| percentage of eyes | Suite | Manual |
|---|---|---|
| Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1 | 80.6 | 69.4 |
Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
| percent-seconds | Suite | Manual |
|---|---|---|
| Cumulative Dissipated Energy (CDE) | 3.396 ± 2.4620 | 4.032 ± 2.6022 |
Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
| ml | Suite | Manual |
|---|---|---|
| Estimated Aspiration Fluid Used During Surgery | 58.6 ± 16.48 | 54.0 ± 11.57 |
Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.
| seconds | Suite | Manual |
|---|---|---|
| Phaco Aspiration Time Spent During Surgery | 197.9 ± 77.06 | 173.3 ± 57.89 |
Collected over Surgery through study completion, an average of 1 month.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Suite (Ocular) | 0/38 (0%) | 1/38 (2.6%) | 0/38 (0%) |
| Manual (Ocular) | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Nonocular | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Event | Suite (Ocular) | Manual (Ocular) | Nonocular |
|---|---|---|---|
| Retinal TearEye disorders | 1/38 | 0/38 | 0/39 |
This analysis population includes all eyes that were randomized and for which an intraocular lens (IOL) was successfully implanted (Full Analysis Set).
| Age, Continuous(years) | All Study Subjects |
|---|---|
| Mean | 67.7 ± 7.8 |
| Sex: Female, Male(Participants) | All Study Subjects |
|---|---|
| Female | 25 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | All Study Subjects |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 38 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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